Gastrointestinal HemorrhagePhase 4NCT02903017
Local Administration of Tranexamic Acid in Upper Gastrointestinal Hemorrhage
A Phase 4 study testing Tranexamic acid 5% in people with Gastrointestinal Hemorrhage and Tranexamic Acid, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
Upper gastrointestinal hemorrhage is a frequently diagnosis in emergency departments. Although new drugs and endoscopic techniques were easily applied in various settings in this condition, the role of local administered therapies such as antifibrinolytic agents remain unclear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Hemorrhage, Tranexamic Acid, Emergency Department
- What is being tested?
- Tranexamic acid 5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2016to Mar 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting with upper gastrointestinal hemorrhage to the ED
- Patients older than 18 years
- Patients who agree to participate the study by reading and signing the informed consent form
Who cannot join
- Patients younger than 18 years
- Patients who do not agree to participate the study
- Documented or declared allergy to tranexamic acid
- Upper gastrointestinal hemorrhage secondary to trauma
- Upper gastrointestinal hemorrhage secondary to esophageal varices
- Patients who cannot undergo to endoscopy for any reason
- History for thromboembolic disease
- Patients with renal impairment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli University, Faculty of Medicine
Kocaeli, 41050
About this study
Official title: Local Administration of Tranexamic Acid in Upper Gastrointestinal Hemorrhage: A Double-Blind, Randomized, Placebo-Controlled Trial
Upper gastrointestinal hemorrhage is a frequently diagnosis in emergency departments. Although new drugs and endoscopic techniques were easily applied in various settings in this condition, the role of local administered therapies such as antifibrinolytic agents remain unclear. The investigators aimed to compare standard therapy (proton pump inhibitors, endoscopic treatments etc.) and standard therapy + local administered tranexamic acid in upper gastrointestinal hemorrhage in a double-blind, randomized trial.
- Conditions
- Gastrointestinal Hemorrhage, Tranexamic Acid, Emergency Department, Antifibrinolytic Agents
- Being tested
- Tranexamic acid 5%, Placebo
- Medical subject headings
- Gastrointestinal Hemorrhage, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid 5%Drug
Via nasogastric tube, 100 mL
PlaceboDrug
Via nasogastric tube, 100 mL
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid 5% | Active comparator | Tranexamic acid 5%, 2000 mg (40 mL) in 60 mL normal saline (0.9%) solution (total 100 mL) Receives: Drug: Tranexamic acid 5% |
| Placebo | Placebo comparator | 0.9% normal saline solution (total 100 mL) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
In- or out of hospital mortality
Measured: One month
Re-bleeding
Recurrent upper gastrointestinal hemorrhage
Measured: One month
Endoscopic intervention need
Measured: One month
Surgical intervention need
Measured: One month
ED revisit
Measured: One month
Secondary outcomes (3)
Length of stay in the hospital
Measured: One month
Administered blood products in the ED
Measured: One month
Adverse reactions
Thromboembolic events, anaphylaxis
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurettin Özgür Doğan, Kocaeli University
- Investigators
- Nurettin Özgür Doğan, M.D., Assoc. Prof., Principal investigator, Kocaeli University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02903017
- Sponsor's protocol ID
- KIA 2016/196
- Status last verified
- Mar 2018
- First submitted
- 12 Sep 2016
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hawkey GM, Cole AT, McIntyre AS, Long RG, Hawkey CJ. Drug treatments in upper gastrointestinal bleeding: value of endoscopic findings as surrogate end points. Gut. 2001 Sep;49(3):372-9. doi: 10.1136/gut.49.3.372.
PubMed 11511559Bergqvist D, Dahlgren S, Hessman Y. Local inhibition of the fibrinolytic system in patients with massive upper gastrointestinal hemorrhage. Ups J Med Sci. 1980;85(2):173-8. doi: 10.3109/03009738009179185.
PubMed 7018048Cormack F, Chakrabarti RR, Jouhar AJ, Fearnley GR. Tranexamic acid in upper gastrointestinal haemorrhage. Lancet. 1973 Jun 2;1(7814):1207-8. doi: 10.1016/s0140-6736(73)90525-4. No abstract available.
PubMed 4122561
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Administration of Tranexamic Acid in Upper Gastrointestinal Hemorrhage: A Double-Blind, Randomized, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT02903017
- Acronym / sponsor ID
- KIA 2016/196
- Conditions
- Gastrointestinal Hemorrhage, Tranexamic Acid, Emergency Department, Antifibrinolytic Agents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 16 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Upper gastrointestinal hemorrhage is a frequently diagnosis in emergency departments. Although new drugs and endoscopic techniques were easily applied in various settings in this condition, the role of local administered therapies such as antifibrinolytic agents remain unclear. The investigators aimed to compare standard therapy (proton pump inhibitors, endoscopic treatments etc.) and standard therapy + local administered tranexamic acid in upper gastrointestinal hemorrhage in a double-blind, randomized trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid 5% | Active comparator | Drug: Tranexamic acid 5%Tranexamic acid 5%, 2000 mg (40 mL) in 60 mL normal saline (0.9%) solution (total 100 mL) |
| Placebo | Placebo comparator | Drug: Placebo0.9% normal saline solution (total 100 mL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients presenting with upper gastrointestinal hemorrhage to the ED
- Patients older than 18 years
- Patients who agree to participate the study by reading and signing the informed consent form
Key exclusion criteria (8 listed)
- Patients younger than 18 years
- Patients who do not agree to participate the study
- Documented or declared allergy to tranexamic acid
- Upper gastrointestinal hemorrhage secondary to trauma
- Upper gastrointestinal hemorrhage secondary to esophageal varices
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acid 5%Via nasogastric tube, 100 mL | Drug | Tranexamic acid 5% |
| PlaceboVia nasogastric tube, 100 mL | Drug | Placebo |
Primary outcome
Mortality
Time frame: One month
In- or out of hospital mortality
Re-bleeding
Time frame: One month
Recurrent upper gastrointestinal hemorrhage
Endoscopic intervention need
Time frame: One month
Surgical intervention need
Time frame: One month
ED revisit
Time frame: One month
3 secondary outcomes
Length of stay in the hospital
Time frame: One month
Administered blood products in the ED
Time frame: One month
Adverse reactions
Time frame: One month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.
- Background: PubMed 11511559Hawkey GM, Cole AT, McIntyre AS, Long RG, Hawkey CJ. Drug treatments in upper gastrointestinal bleeding: value of endoscopic findings as surrogate end points. Gut. 2001 Sep;49(3):372-9. doi: 10.1136/gut.49.3.372.
- Background: PubMed 7018048Bergqvist D, Dahlgren S, Hessman Y. Local inhibition of the fibrinolytic system in patients with massive upper gastrointestinal hemorrhage. Ups J Med Sci. 1980;85(2):173-8. doi: 10.3109/03009738009179185.
- Background: PubMed 4122561Cormack F, Chakrabarti RR, Jouhar AJ, Fearnley GR. Tranexamic acid in upper gastrointestinal haemorrhage. Lancet. 1973 Jun 2;1(7814):1207-8. doi: 10.1016/s0140-6736(73)90525-4. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nurettin Özgür Doğan, M.D., Assoc. Prof. principal investigator
Kocaeli University, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic acid 5% in people with Gastrointestinal Hemorrhage and Tranexamic Acid, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: One month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02903017, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2018.